Pylera

PYLERA- bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule
Allergan, Inc.

WARNING: POTENTIAL FOR CARCINOGENICITY

Metronidazole has been shown to be carcinogenic in mice and rats . It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions (5.1) ] .

1 INDICATIONS AND USAGE

1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease

PYLERA in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence.

1.2 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (Table 1).

Table 1: Daily Dosing Schedule for PYLERA
Time of dose Number of capsules of PYLERA Number of capsules of omeprazole 20 mg
After morning meal 3 1
After lunch 3 0
After evening meal 3 1
At bedtime 3 0

Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.

If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.

3 DOSAGE FORMS AND STRENGTHS

Each PYLERA capsule contains 140 mg of bismuth subcitrate potassium, 125 mg of metronidazole, and a smaller capsule inside containing 125 mg of tetracycline hydrochloride. The capsules are white and opaque, with the APTALISTM logo printed on the body and “BMT” printed on the cap.

4 CONTRAINDICATIONS

4.1 Methoxyflurane

Do not administer methoxyflurane to patients taking PYLERA. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in fatal renal toxicity [ s ee Drug Interactions (7.1)].

4.2 Disulfiram

PYLERA is contraindicated in patients who have taken disulfiram within the last two weeks. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of PYLERA, and disulfiram concurrently [ s ee Drug Interactions (7.2)].

4.3 Alcohol

Alcoholic beverages or other products containing propylene glycol should not be consumed during and for at least 3 days after therapy with PYLERA. A disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) may occur due to the interaction between alcohol or propylene glycol and metronidazole, a component of PYLERA [ s ee Drug Interactions (7.3)].

4.4 Cockayne Syndrome

PYLERA is contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome [see Adverse Reactions (6.3)].

4. 5 Severe Renal Impairment

PYLERA is contraindicated in patients with severe renal impairment. The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN) [ s ee Adverse Reactions (6.3)]. In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis.

4. 6 Pregnancy

PYLERA is contraindicated during pregnancy [see Use in Specific Populations (8.1)].

4 .7 Hypersensitivity Reactions

PYLERA is contraindicated in patients with known hypersensitivity (e.g. urticaria, erythematous rash, flushing, and fever) to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracycline [ see Adverse Reactions (6.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Carcinogenicity

Metronidazole, a component of PYLERA, has been shown to be carcinogenic in mice and rats. Tumors affecting the liver, lungs, mammary and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters [ see Nonclinical Toxicology (13)]. It is unknown whether metronidazole is associated with carcinogenicity in humans.

5.2 Fetal Toxicity

Tetracycline can cause fetal harm when administered to a pregnant woman. Based on animal data, use of drugs of the tetracycline class during the second and third trimester of pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development [ see Warnings and Precautions (5.4)]. Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals. If PYLERA is used during pregnancy, or if the patient becomes pregnant while taking PYLERA, advise the patient of the potential risk to the fetus [ see Contraindications (4.6) and Use in Specific Populations (8.1)].

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